FDA Orders Recall of Popular Blood Pressure Medication Valsartan
Edward Neeman | Published: August 09, 2018
If you’ve ever encountered blood pressure issues then you may be familiar with the popular prescription medication known as Valsartan. The drug, shown to be highly effective against high blood pressure, but also used to treat more serious conditions like heart failure, has recently been placed under an international recall. The recall stems from findings that pharmaceuticals containing Valsartan may also contain cancer-causing chemicals. It should be mentioned that only a few, specific makers of the drug are affected.
Initially, it was thought that manufacturers of the drug in the United States would not be affected, and early studies seemed to indicate that only generic versions of Valsartan were a cause for concern. The Food and Drug Administration (FDA) has since reassessed the drug’s usage in the U.S. and determined that several manufacturers here are selling versions of Valsartan with the harmful chemical additive.
What Is The FDA Saying On Valsartan?
The FDA’s most recent findings have shown a high incidence of the chemical N-nitrosodimethylamine, otherwise known as NDMA, in Valsartan-related drugs.
If you are not familiar with the chemical, NDMA has not only been shown to have carcinogenic effects but also has a negative effect on liver and organ function. NDMA researched has been largely based on animal studies, with the FDA noting that the chemical is a “probable” carcinogen and, in small quantities, is harmless. In fact, small amounts of NDMA are often found in municipal water supplies and a variety of common foods.
If NDMA is a known carcinogen, you may also be wondering why it is in commonly prescribed medications. The FDA believes that the manufacturing techniques for certain forms of Valsartan lead, via certain chemically induced reactions, to the unintentional creation of NDMA.
The FDA also believes that the amounts of NDMA they are finding in Valsartan are small enough that very few people would be affected, in practice, but even small risks shouldn’t be ignored. It is estimated that only one out of every 8,000 people using Valsartan at the highest doses over a 4-year period are at risk for developing cancer.
Which Manufacturers Are Affected?
The FDA Director of Drug Evaluation and Research has stated that not all forms of Valsartan are dangerous. Per the FDA findings, you should only avoid Valsartan if it is manufactured by the following companies:
- Bryant Ranch Prepack Inc.
- H.J. Harkins Company Inc.
- Lake Erie Medical/Quality Care Products LLC
- NuCare Pharmaceuticals Inc.
- Northwind Pharmaceuticals
- Prinston Pharmaceuticals Inc.
- Proficient RX
- Teva Pharmaceuticals
It should be noted that not all versions of Valsartan manufactured by these companies contain NDMA. Northwind Pharmaceuticals sells a version of Valsartan for example, known as Valsartan/Hydrochlorothiazide (HCTZ), that is free of the worrying chemical.
Are There Any Alternatives?
There are a number of manufacturers the FDA has deemed as safe suppliers of Valsartan, so if you do take this drug, the following manufacturers are not included in the recall:
- Alembic Pharmaceuticals Limited
- Allergan, Inc.
- American Health Packaging
- Amneal Pharmaceuticals LLC
- Aphena Pharma Solutions
- Apotex Corp.
- Aurobindo Pharma Limited
- Cardinal Health
- Carilion Materials Management
- Gavis Pharmaceuticals, LLC
- Jubilant Cadista Pharmaceuticals Inc.
- Lucid Pharma
- Macleods Pharmaceuticals USA
- Novartis Pharmaceuticals Corp.
- Novel Laboratories, Inc.
- Ohm Laboratories, Inc.
A full list of every Valsartan product deemed safe by the FDA is available online.
Should You Stop Taking Your Valsartan?
For now, the FDA is advising that if you are already taking Valsartan, you should continue using the product you have until a new a prescription can be obtained from a doctor. If you find your Valsartan manufacturer on the recall list, continue using the drug as instructed, but you should reach out to your pharmacist or your doctor to discuss a replacement.